FDA approves new dosages for bipolar schizophrenia drug

April 25, 2022

1 minute read


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The FDA has granted approval to Intra-Cellular Therapies Inc. for 10.5 mg and 21 mg doses of lumateperone to treat schizophrenia and bipolar depression, according to a company statement.

Lumateperone (Caplyta, Intra-Cellular) is indicated in adults both as monotherapy and as an add-on treatment with lithium or valproate and is available in 42 mg capsules, the company said in a press release.

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“Caplyta 42mg demonstrated efficacy in the treatment of bipolar depression and schizophrenia with a favorable profile on weight, metabolic parameters and extrapyramidal symptoms (movement disorders)”, Suresh Durgam, MD, executive vice president and chief medical officer of intracellular therapies, said in the statement. “Our label now provides dosage recommendations for specific patient needs. We believe Caplyta’s label reflects a strong clinical profile and provides prescribers with the information needed to prescribe this important drug.

The new assays are expected to be available by mid-2022.

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